N/A
N=320
Improving Women's Health Through Coordinated Postpartum Planning
Maternal Death · Maternal Morbidity
Bottom Line
View on ClinicalTrials.gov: NCT05430815 ↗Enrolled (actual)
320
Serious AEs
5.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants Attending a Comprehensive Postpartum Visit — 84; 89 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Postpartum Care System (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Attending a Comprehensive Postpartum Visit |
84; 89 | — |
| SECONDARY Number of Participants Attending Any Postpartum Visit |
109; 116 | — |
| SECONDARY Number of Participants for Whom Postpartum Diabetes Screening Was Ordered |
18; 26; 141; 135 | — |
| SECONDARY Number of Participants for Whom Postpartum Diabetes Screening Was Performed |
9; 14; 150; 147 | — |
| SECONDARY Number of Participants With Diabetes for Whom Postpartum Diabetes Screening Was Ordered |
14; 19; 22; 26 | — |
| SECONDARY Number of Participants With Diabetes for Whom Postpartum Screening Was Performed |
8; 11; 28; 34 | — |
| SECONDARY Number of Participants Receiving Postpartum Hypertension Screening |
80; 81 | — |
| SECONDARY Number of Participants With Hypertension Receiving Postpartum Hypertension Screening |
45; 48 | — |
| SECONDARY Number of Participants Using Contraception |
119; 117; 86; 85 | — |
| SECONDARY Number of Participants Using Medication |
21; 29; 17; 9 | — |
| SECONDARY Number of Participants With Ongoing Pregnancy Complications |
2; 3; 4; 8 | — |
| SECONDARY Number of Participants Readmitted to the Hospital |
6; 10; 16; 20 | — |
| SECONDARY Perceived Risk of Severe Maternal Morbidity (SMM) |
35; 34; 66; 76; 40; 31 | — |
| SECONDARY Perceived Risk of Cardiovascular Disease |
55; 58; 26; 31; 60; 52 | — |
| SECONDARY Number of Participants Using Primary Care |
73; 79 | — |
| SECONDARY Number of Participants Using Specialty Care |
94; 73 | — |
| SECONDARY Number of Participants With Depression Per Edinburgh Postnatal Depression Scale (EPDS) Score |
37; 26; 88; 92; 16; 23 | — |
| SECONDARY Satisfaction With Postpartum Care |
88; 81; 90; 79; 91; 82 | — |
| SECONDARY Satisfaction With Provider at Postpartum Care Visit |
4.7; 4.7; 4.7; 4.6; 4.7; 4.6 | — |
| SECONDARY Number of Participants in Self-rated Categories of Postpartum Health at 12 Weeks After Delivery |
47; 50; 18; 23; 43; 32 | — |
| SECONDARY Number of Participants in Self-rated Categories of Postpartum Health at 14 Months After Delivery |
31; 29; 23; 31; 41; 33 | — |
Summary
The purpose of the study is to design, implement, and evaluate a holistic postpartum women's health care system for women who have cardiovascular risk factors for severe maternal morbidity (SMM) including chronic hypertension, chronic diabetes, gestational diabetes, pre-pregnancy obesity, or a hypertensive disorder of pregnancy (HDP) which includes gestational hypertension or preeclampsia. The researchers will use a sequential mixed methods design. First, the researchers will conduct in-depth interviews with women who have given birth in the prior year to characterize barriers and facilitators to accessing postpartum care. The information from these interviews will be used to inform the design of a postpartum care system. Next, the researchers will conduct a pragmatic randomized trial to test the effectiveness of the system on postpartum care engagement versus standard of care.
Eligibility Criteria
Inclusion Criteria
- pregnant women between 20-34 weeks of gestation
- have received 1 or more prenatal care visits at Grady Memorial Hospital in Atlanta, Georgia (GA)
- intend to deliver at Grady Memorial Hospital
- speak English or Spanish
- have a diagnosis of chronic diabetes, chronic hypertension, gestational diabetes, pre-pregnancy obesity (body mass index [BMI] of 30 or greater), and/or a hypertensive disorder of pregnancy (gestational hypertension or preeclampsia) documented in the electronic medical record (EMR)
Exclusion Criteria
- adults unable to consent, infants, and prisoners
Data sourced from ClinicalTrials.gov (NCT05430815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.